Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorAnkit Mangla, MD
About this trial
People who have a cancer called MPNST, or Malignant Peripheral Nerve Sheath Tumor, may be eligible for this study. The purpose of this study is to see if a new medicine called BMS-986504 may work better than other available medicines for people with MPNST. Methylthioadenosine Phosphorylase (MTAP) loss is a gene mutation that some people have. MTAP loss seems to increase the chance that BMS-986504 can kill MPNST cancer cells. People who are missing MTAP from their tumor may be able to enroll in this study. Treating MPNST based on MTAP loss is considered experimental and is not approved by the US Food and Drug Administration (FDA) for determining whether BMS-98650 will be active against cancer. The purpose of this study is to evaluate the safety and effectiveness of BMS-986504 in participants with MPNST.
Eligibility criteria
Qualifiers
Male or female participants ≥ 12 years of age at the time of screening.
Ability to understand and willingness to sign documentation of informed consent if ≥ 18 years of age or documentation of assent if 12-17 years of age.
Pathohistological verification of MPNST.
Measurable disease (size of primary tumor and metastatic lesions can be trended by CT or MRI scans).
Disqualifiers
Participants who have been treated previously with a PRMT5 inhibitor.
Participants who are unable to swallow tablets.
History of gastrointestinal disease, inflammatory bowel disease, major gastric surgery or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
Participants with active drug use.
Trial design
Treatments tested in this trial
- BMS-986504
Treatment groups
17 Participants
are divided into 1 treatment groupSponsors and collaborators
Ankit Mangla, MD
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov